NCT00388635

Velcade-Melphalan-Prednisone in Older Untreated Multiple Myeloma Patients.

A National, Multi-Center, Open-Label Study of Velcade in Combination With Melphalan and Prednisone (V-MP) in Older Untreated Multiple Myeloma Patients.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: PETHEMA Foundation · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This protocol is planned as a multicentric, national, open-label trial designed to evaluate, first, optimal dose of Velcade® (Bortezomib) in combination with melphalan and prednisone. After optimal dose is known, the second aim is evaluate safety and tolerance of V-MP plan, in respond terms, in a cohort of 60 patients. Finally, the entire results will be compared with those obtained from a series of 100 patients, all of them over 70 years old, diagnosed of Multiple Myeloma belonging to the GEM protocol finished in May 2003

Detailed description

Multiple Myeloma is a neoplastic disorder of the last maturation stage of B cell, called plasmatic cell. It represents the second most common haematological neoplasia, after Non Hodgkin Lymphoma. The annual incidence is over 4 cases per 100.000. Multiple Myeloma is an invariably mortal disease. When illness advances, the reduction of infections resistance, the intense bones destruction (with bone pain, pathological fractures and hypercalcemia), anaemia, renal failure and, in a less frequency, neurological complications and hyperviscosity provoke severe morbidity and mortality. Five-year survival rate in patients with Multiple Myeloma treated with conventional chemotherapy is 29%. There is an urgent need of new therapeutic agents for the treatment of this disease

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Velcade	Phase I: Velcade, 1.0mg/m2-1.3mg/m2 in escalating doses every 6 weeks for 4 cycles Pase II: Velcade at optimal doses, twice a week (days 1, 4, 8, 11, 22, 25, 28 and 32) follow a rest period for 10 days (days 33 to 42)
DRUG	Melphalan	Melfalán 9mg/m2 days 1 to 4, V.O, follow by a rest period of 38 days in phse I and II
DRUG	Prednisone	Prednisone 60mg/m2 v.o days 1 to 4 follows by a rest period of 38 days (phase I and II)

Timeline

• Start date: 2004-04-01
• Primary completion: 2007-01-01
• Completion: 2008-12-01
• First posted: 2006-10-17
• Last updated: 2011-01-11

Locations

19 sites across 1 country: Spain